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CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

Recruiting
10-60 years
All
Phase 1
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Overview

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Description

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Eligibility

Inclusion Criteria:

  1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
  2. ALT/ AST 《 3x normal
  3. Creatinine 《 3x normal
  4. Age:10-60.
  5. Signed informed consent

Exclusion Criteria:

  1. Active hepatitis B , hepatitis C or HIV infection
  2. Uncontrolled active infection
  3. Pregnancy or breast-feeding women
  4. Survival less than four weeks

Study details
    B-cell Acute Lymphocytic Leukemia

NCT03064269

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

26 January 2024

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